Prophylactic device

ABSTRACT

A prophylactic device is described which is adapted to be worn by a person to prevent the transmission of disease and sperm during sexual intercourse. The device may be adapted for use by a female person or by a male person. The device includes an elongated hollow pouch which has an open end and a closed end. The pouch has a thin wall member which is flexible and elastic. A continuous flange member is attached to the open end of the pouch and extends outwardly around the opening in the pouch. Attachment means secured to the flange attaches the device to the person wearing it. The device may be in the form of a garment worn by the person.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a division of Ser. No. 343,497, filed Apr. 24, 1989,now U.S. Pat. No. 4,993,433, which is a Continuation-In-Part of mycopending application Ser. No. 084,622, filed Aug. 11, 1987, now abandonwhich, in turn, is a continuation-in-part of my copending applicationSer. No. 7,104, filed Jan. 27, 1987 now abandoned.

FIELD OF THE INVENTION

This invention relates to prophylactic devices. More particularly, thisinvention relates to prophylactic devices which are highly effective inpreventing the transmission of venereal diseases and AIDS. Even moreparticularly, this invention relates to prophylactic devices which maybe used by females. The invention even more specifically relates toprophylactic devices of universal application for shielding the perineumof females and males by use of a disposable shield component which iscomfortably configured for use in either application.

BACKGROUND OF THE INVENTION

With the widespread occurrence of venereal diseases and AIDS (AcquiredImmune Deficiency Syndrome), there is an increasing need for aneffective means of preventing the transmission of such diseases throughsexual contact. Conventional means for preventing the transmission ofsuch diseases include the use of condoms, diaphragms, gels, creams, etc.However, such conventional means are not totally effective, even whenthey are used in combination with one another.

There has not heretofore been provided an effective prophylactic devicefor females persons which prevents the transmission of diseases duringsexual intercourse.

The prior prophylactic devices for female persons which have been usedheretofore include U.S. Pat. No. 3,536,066 having a bellows formedproboscis thereon which is joined to a pant style unitized garmentwithout any straps, tapes or buttons thereon. The contraceptive deviceof the -066 patent includes an insertable portion of a bellows which ispositioned in the vaginal canal of a female prior to use. Thereafter,the bellows is expanded by an erected penis to provide for expansion ofthe bellows during coitus with the female person on which thecontraceptive device is used. The device requires preinsertion and doesnot include means for piloting a large pouch-like member into thevaginal canal. Furthermore, the garment portions thereof are in contactwith a large part of the waist region of a user so as to cause possibleirritation and discomfort.

U.S. Pat. No. Des. 254,808 to Meldahl discloses a design of a malecontraceptive. While the contraceptive appears to be larger in diameterthan the average condom, it does not have any structure at the open endthereof to serve as a shield to cover perineum regions of the user ofthe device so as to prevent passage of bodily fluids to such regions.

German Patentschrifft No. 210413 (1909) discloses a female contraceptivedevice having a proboscis, or pouch, on one end thereof and having agenerally circular collar on the other end thereof which covers a smallpart of the entrance to a vaginal canal or other bodily orifice.

U.S. Pat. No. 4,735,621 likewise shows a thin walled condom-like tubularprotective device for insertion in a vaginal canal. It includes aresilient ring on one end thereof to provide an internal anchor, muchlike a diaphragm.

The prophylactic device of the -621 patent includes a collar on itsentrance end which, again, is limited to covering a small part of theentrance to the vaginal canal. The device requires hand insertion to setthe internal anchor and thereby exposes a user to bodily fluids andpossible transmission of diseases through lesions or the like during thehand transfer and placement of the contraceptive device in the bodyorifice.

Each of the aforesaid prophylactic devices are characterized by eitherproviding a limited exterior cover at the opening of a body cavity suchas a vaginal canal or an anal canal or alternatively a garment typeprophylactic device that will cover the full body of a user below thewaist. The first type of prophylactic device requires separate handinsertion into the vaginal canal, thereby exposing a user to the bodilyfluids therein and the second type of device is uncomfortable if wornfor extended periods prior to use.

SUMMARY OF THE PRESENT INVENTION

In accordance with the present invention there is provided aprophylactic device which is adapted to be worn by a person to preventthe transmission of disease and also sperm during sexual intercourse.The device comprises:

(a) An elongated hollow pouch having first and second ends; wherein thefirst end is closed and the second end includes an opening; wherein thepouch includes a thin wall member which is flexible and preferablyelastic;

(b) a continuous flange member which is attached to the second end ofthe pouch and which extends around the circumference of the opening; and

(c) attachment means which is adapted to attach the device to theperson.

The prophylactic device of the invention, in one embodiment, can be wornby a female person. In such embodiment the first end of the pouchoptionally includes a resilient portion which is adapted to be grippedand retained in position by the muscles in the vagina of the female. Inanother embodiment the prophylactic device can be worn by a male person.In another embodiment, the prophylactic device is made from two layersof generally inelastic plastic film material joined at the periphery byheat sealing or dielectric bonding.

In yet another embodiment, the prophylactic device is anatomicallyconfigured to serve as a universal prophylactic device for either maleor female use. The universal prophylactic device has a generallyrectangularly configured shield portion that will cover the perineum andthe gluteal regions of a male person from the gluteal region of suchmale person to the scrotum regions of such male person. Such device isdimensioned to cover the perineum region of a female person from theupper pubic region to the perineum region in the vicinity of the analcanal of the female person. Such shield portion prevents the contact ofbodily fluids with such perineum regions during use of the prophylacticdevice. The universal prophylactic device further is characterized ashaving a rolled pouch segment thereon initially disposed substantiallyin the same plane as the rectangular shield portion of the prophylacticdevice The rolled pouch has a first telescopingly extended pilotingposition for entry into a body orifice such as a flaccid anal canal of amale person or a vaginal canal of a female person. The pouch isdimensioned to have the smallest dimension thereof greater than theouter dimensions of an erected penis of a male person.

The pouch portion can be extensible inwardly of a body orifice beyondthe initial piloting position of the pouch by unrolling anddetelescoping the pouch portion into the body cavity during penetrationof the erected penis therein so as to define an extended pouchconfiguration that will permit free lateral movement of a penis within abody orifice.

The pouch can be configured to abe fully inserted into a vagina by anerected penis to define a space within the vagina bounded by the pouchand permitting stroking motion of the penis with respect to the clitoralregion of the vagina by a rolling motion of a wall segment of theextended pouch therein.

A feature of one embodiment of the present invention is an anatomicallyconfigured hermaphroditic prophylactic device which is configured to befastened on either a female person or a male person to locate a pouchportion thereof for disposition into a body cavity without requiringinsertion of a hand or tool into the bodily orifice; and wherein thepouch is connected to a generally rectangularly configured shield thathas a width and a length to cover the full perineum of either the femaleuser or the male user when the pouch is disposed in either a vaginalcanal or an anal canal during use.

A further feature of the present invention is to provide an anatomicallyconfigured hermaphroditic prophylactic device of the type set forth inthe preceding object wherein the pouch is preformed to have telescopedsegments thereon rolled to form a flat planar prophylactic device whichcan fit in a preuse position over the perineum of a female or a maleuser and wherein the telescoped segments are extendable during a firstpenetration of a male organ into a body cavity to extend a first segmentof the pouch portion in a piloted relationship into a first depth of thebody cavity and wherein the pouch will unroll into a fully extendedfurther depth position within the body cavity upon continued insertionof the male organ therein.

Yet another object of the present invention is to provide a prophylacticdevice having the features set forth above wherein the pouch has aminimum interior dimension thereof substantially greater than that ofthe outer surface dimensions of an erected penis to provide for freedomof movement internally of a bodily orifice such as the vaginal canal ofa female user to reduce surface pressure on the penis during coitus bythe female user and wherein the length of the pouch is selected topermit an extension and rolling movement of a wall segment portion ofthe pouch with respect to a clitoral region at the entrance of thevaginal canal to enhance direct pleasurable contact with the clitoralregion during coitus.

Still another feature of the present invention is that the prophylacticdevice having the features set forth above is formed by a dippingprocess wherein the pouch is formed on a first portion of a mold and theexternal shield is formed on a second portion of the mold by a relativemovement of the mold within a dipping bath of latex or other suitablematerial for manufacture of a flexible prophylactic device of polymericmaterial.

Yet another feature of the present invention is to provide ananatomically configured hermaphroditic prophylactic device of the typeset forth above and including the method of manufacture as set forthabove wherein the prophylactic device can be removed from the mold byfirst disposing the shield portion in spaced relationship to the moldsurface to form telescoped segments on the shield portion and thereafterproviding means to roll the telescoped segments into a tightconfiguration substantially located in the plane of the shield portionpreviously stripped from the mold and wherein the planar shield androlled pouch portions are turned end for end to reduce the outerdimensions of the prophylactic device for automatic packaging.

Still another object of the present invention is to provide a packagingprocess of the type set forth in the preceding paragraph wherein thefolding step includes a first end to end folding of the planar disposedshield and rolled pouch portions with a subsequent rolling of thefolding segments into a tubular configuration for insertion in a tubularcontainer.

Still another object of the present invention is to provide a packagingprocess wherein the planar shield and rolled pouch portions are foldedend to end three times to form an eight layered compact prophylacticconfiguration for packaging in flat container configurations.

With the device of this invention, the transmission of diseases andsperm is effectively prevented during sexual contact. The device can bemade as a disposable item or as a reusable item. It can be made frominexpensive materials.

The prophylactic device may be in the form of a garment which is wornaround the pelvic region. Alternatively, the prophylactic device may beattached to the wearer by other means (e.g., by means of straps,adhesive, tape, etc.).

In yet another embodiment of the invention, the prophylactic d vice isanatomically configured hermaphroditic prophylactic device adapted to beconnected to a strap configuration which for a male person includesfrontal strap segments that will position the anatomically configuredshield portion of the hermaphroditic prophylactic device in a clearancerelationship with the scrotum of a male person and which furtherincludes short strap segments for extending the shield portion of such aprophylactic device into a full perineum covering relationship with themale person in surrounding relationship to the extendable rolled pouchportion thereof so as to prevent contact of bodily fluids of anotherperson with the perineum region and bodily orifices of a male personuser of the prophylactic device. Alternatively, the anatomicallyconfigured, hermaphroditic prophylactic device of the present inventionmay be incorporated as part of a strap support or a bikini pantconfiguration for a female user. The pant is of a suitable comfortablefabric including an elastic waist portion and an extended buttocksengaging rear portion (or long strap segments) that will position oneend of the shield portion of such prophylactic device to cover theperineum of a female person from the anal region thereof to the vulva.The bikini garment or female strap support further includes a frontalportion thereof with short strap segments that connect the opposite endof the shield portion of the such prophylactic device to the waistportion so as to locate the shield portion of such prophylactic deviceto cover the perineum of a female person from the vulva to the upperpubic region.

In another aspect of the present invention, the strap and/or garmentsupport for locating the anatomically configured, hermaphroditicprophylactic device is connected to the strap or garment components byreleasable snap means that are configured to permit noncontact removalof the prophylactic device from the strap or garment components once theprophylactic device has been removed from the user so as to extract thepouch portion of the prophylactic device from the bodily orifice.Consequently, the garment mounted anatomically configured hermaphroditicprophylactic device of the invention can be handled without exchange ofbodily fluids to hand or other lesions through which disease can betransmitted.

Still another feature of the anatomically configured hermaphroditicprophylactic device of the present invention is that it is easilyremoved from standard molding equipment to form a flat form having theperimeter thereof bounded by the planar extent of the shield portion ofsuch prophylactic device and the rolled pouch portion thereof disposedin the same plane as that of the shield and wherein such planarconfiguration can be first folded on itself and then rolled to form acompact, easily packaged prophylactic component and protecting the pouchat the same time and/or can be folded twice on itself to form a compact,eight layered, generally rectangularly configured unit that is suitablefor packaging in flat container packages of various forms and shapes.

Other advantages of the devices of this invention will be apparent fromthe following detailed description.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention is described in more detail hereinafter with reference tothe accompanying drawings, wherein like reference characters refer tothe same parts throughout the several views and in which:

FIG. 1 is a front perspective view of one embodiment of prophylacticdevice of this invention;

FIG. 2 is a side elevational view of the embodiment of prophylacticdevice shown in FIG. 1;

FIG. 3 illustrates the embodiment of prophylactic device of FIG. 1 whilebeing worn by a female person;

FIG. 4 is a perspective view of another embodiment of prophylacticdevice of the invention for use by a female person;

FIG. 5 is a perspective view of another embodiment of prophylacticdevice of the invention for use by either a male or a female person;

FIG. 6 is a partially cut away, perspective view of another embodimentof prophylactic device of the invention;

FIG. 6A is a cross-sectional view of a portion of the device of FIG. 6;

FIG. 7 is a cross-sectional view of a portion of another device of theinvention;

FIG. 8 is a perspective view illustrating another embodiment ofprophylactic device of this invention;

FIG. 9 is a side view of the device illustrated in FIG. 8;

FIG. 10 is a perspective view of another embodiment of prophylacticdevice of this invention;

FIG. 11 is a perspective view of yet another embodiment of a device ofthis invention;

FIG. 12 is a front perspective view of a mold which is useful in theproduction of a device of this invention;

FIGS. 13a and 13b illustrate a preferred manner of telescoping androlling the pouch member of a device of this invention;

FIG. 13c shows a device of the invention in which the pouch member isrolled;

FIG. 14 is a perspective view of an anatomically configuredhermaphroditic embodiment of the invention on a male person;

FIG. 15 is a fragmentary sectional view taken along the line 15--15 inFIG. 14;

FIG. 15a is a view showing the prophylactic device of FIG. 15 in a firstextended position for piloting the pouch portion thereof into a bodycavity of either a male or a female person;

FIG. 15b is a sectional view showing the pouch portion of theprophylactic device of either FIG. 14 or FIG. 16 in a fully extendedposition within the body cavity of a male or female person;

FIG. 15c is a sectional view showing the dimensional relationship of ananatomically configured hermaphroditic prophylactic device with thepouch portion thereof extended and in spaced relationship to an erectedpenis within a vaginal canal to provide freedom of and lateral movementwith respect to the inner walls of the extended pouch portion of suchprophylactic device;

FIG. 15d is a fragmentary view of the pouch wall at the clitoral regionof a vaginal canal;

FIG. 15e is a fragmentary view of a stroking roll in the pouch wall ofFIG. 15d;

FIG. 16 is a diagrammatic view of a further embodiment of ananatomically configured hermaphroditic prophylactic device on a femaleperson;

FIG. 17 is an enlarged fragmentary detail of a releasable fastener forsecuring a shield portion of the prophylactic devices of either FIG. 14or FIG. 16 to garments or components thereof;

FIG. 18 is a diagrammatic view of dipping and tilting steps in a processof the present invention for manufacturing anatomically configuredprophylactic devices;

FIG. 19 is a diagrammatic view showing a stripping step of such processsteps of FIG. 18;

FIG. 20 shows a rolling step wherein telescoped segments of the pouchare rolled into generally the same plane as that of the shield portionof such prophylactic device; and

FIG. 21 is a sectional view taken along the line 21--21 of FIG. 25;

FIG. 21a is an enlarged sectional view of a segment of a partiallydetelescoped pouch;

FIG. 22 is a perspective view of a first fold step in packaging aprophylactic device formed by the steps of FIGS. 18 through 20;

FIGS. 22a-22c are perspective view of an embodiment for folding theprophylactic device;

FIG. 23 is a rolling step for configuring the folded prophylactic deviceof FIG. 22 in a tubular form for subsequent packaging;

FIG. 24 is an exploded view of a folded and rolled prophylactic devicein an aligned, preassembled relationship with a tubular container forsuch prophylactic device;

FIG. 25 is a front elevational view of another embodiment of theprophylactic device;

FIG. 26 is an end elevational view of the embodiment of FIG. 25;

FIG. 27 is a side elevational view of the FIG. 25 embodiment; and

FIG. 28 is a perspective view of an inelastic plastic film embodiment ofthe present invention.

DETAILED DESCRIPTION OF THE INVENTION

In FIGS. 1 and 2 there is illustrated one embodiment of a prophylacticdevice 10 which is in the form of a garment (i.e., a brief) which can beworn around the pelvic region The garment includes an elongated hollowpouch 12 having a first end 14 which is closed and a second end 16 whichis open.

The pouch has a thin wall member which is flexible and elastic.Preferably the pouch is made of rubber which may be natural orsynthetic. Other synthetic materials can also be used (e.g.,polyurethane, polyvinylchloride, silicone elastomer, etc.). Thethickness of the wall member is in the range of about 0.0005 to 0.1inch, and preferably in the range of about 0.001 to 0.005 inch.

The second end of the pouch, i.e., the open end is attached to thegarment in the manner shown in FIG. 1 is a manner such that a portion ofthe garment forms a flange around the circumference of the opening inthe pouch. Preferably the pouch is molded as an integral part of thegarment. Alternatively, the pouch may be formed separately and thenbonded to a corresponding opening in the garment. For example, the pouchmay be permanently bonded to the garment or it may be detachablyconnected by means of adhesive, or with snaps, or with a fastener systemof the type including an elongated bead or ridge on one component and anexpandable receptive groove on the other component (e.g., such as iscommon with certain sandwich bags).

As illustrated in FIGS. 1 and 2, the hollow pouch may be invertable. Inthese views the pouch is shown in dotted lines to illustrate theposition of the pouch within the vagina of a female person wearing thegarment. When putting on the garment, the pouch may be in the outwardposition illustrated in these figures. It is also easier to applydesired lubricants and a spermatocide (e.g., such as that commerciallyavailable under the name Nonoxonal 9) to either the interior or exteriorof the pouch. Typically these materials are applied to both the interiorand exterior surfaces of the pouch. Then the pouch is inverted andinserted into the vagina (as illustrated in FIG. 3).

The closed end 14 of the pouch optionally includes a resilient memberwhich is adapted to be gripped and retained in position by the vaginalmuscles (i.e., the labia muscles). Thus, when the pouch in inserted intothe vagina as illustrated in FIG. 3, the labia muscles are capable ofgripping and retaining the end 14 of the pouch in the position shown.

The resilient member at the closed end of the pouch may be a resilientdisc 50 (as illustrated in FIG. 7) which is preferably flexible. Thedisc may be made of rubber of plastic. Preferably it is molded as anintegral part of the pouch wall 52.

Another embodiment of resilient member is illustrated in FIGS. 6 and 6Awhere it comprises a disc member 40 which includes a ring shaped springor wire 41. The disc 40 may be deformed or folded to facilitateinsertion into the vagina, and then the spring or wire 41 urges the discmember back to its original circular shape. The disc member 40 may beformed as an integral part of the wall member of the pouch 42 or it maybe formed separately and then bonded to the wall member.

Another embodiment of the prophylactic device 20 is illustrated in FIG.4. In this embodiment, the hollow pouch 22 has a closed end 23 and anopen end 24. The open end of the pouch is attached to and surrounded bythe continuous flange member 25, as illustrated. The flange extendsoutwardly at least one inch, and preferably at least three inches,around the open end of the pouch.

The flange member in the devices of this invention may be both flexibleand elastic, although neither or such features is required. For example,the flange may be flexible but nonelastic. It is also possible for theflange to be nonflexible (e.g. a plastic member) It is necessary for theflange to be liquid impermeable, however.

In the embodiment shown in FIG. 4, the flange member has a plurality ofstrap members 26 secured thereto. These strap members are connected attheir opposite ends to band 26 which may be worn around the waist oraround the pelvic region of the female person using this device. Theflange member and the pouch prevent transmission of sperm and diseasesfrom one person to the other.

In FIG. 5, there is illustrated another embodiment 30 of prophylacticdevice of the invention. This embodiment is adapted for use by either amale or female person. The device comprises an elongated hollow pouch orsheath 33 which is closed at its outer end 32. The opposite end 34 isopen and it is attached or secured to flange member 35. The flangemember extends outwardly around the circumference of the opening in thepouch at least one inch, and preferably at least three inches. Strapmembers 36 are secured at one end to flange member 35 and are secured atthe opposite end to band 37 which may be worn around the waist or aroundthe pelvic region of the person using this device. The pouch and theflange member prevent the transmission of diseases from one person tothe other. The pouch also prevents sperm from being transmitted. Ofcourse, the device of FIG. 5 could instead be in the form of a brief tobe worn by the person using it, if desired.

In FIGS. 8 and 9 there is illustrated another embodiment of prophylacticdevice of the invention in which the pouch member is detachable. Thus,there is shown an elongated pouch member 60 having a closed end 61 andan open end 63. Surrounding open end 63 is a rim member 62 which isadapted to lay against flange 64 and may be detachably secured to flange64 by means of adhesive, for example. Other useful means for securingrim 62 to flange 64 include snaps, buttons, adhesive tape, bead andgroove fastener systems, hook and loop fastener systems, etc. In thearrangement of FIGS. 8 and 9, for example, the pouch member may bedetached and discarded after use.

The flange member 64 may be part of a garment (such as illustrated inFIGS. 1 and 2) or it may be the type shown in FIGS. 4 and 5.

FIG. 10 illustrates another embodiment of prophylactic device of thisinvention. In this embodiment, an elongated hollow pouch 70 has oneclosed end 71 and an open end 73. Flange member 74 surrounds thecircumference of the open end 73, as illustrated. Strap members 74 aredetachably secured to flange member by means of conventional snaps 76.Thus the pouch and flange may be detached and discarded after use.

In yet another variation, the pouch member 70 may be used without strapmembers. For example, the flange 74 may be secured to the skin of theperson wearing the device by means of adhesive or with adhesive tape, ifdesired.

FIG. 11 illustrates another embodiment of device 80 of the inventioncomprising strap or belt member 82, flange member 84, and elongatedhollow pouch 85. The lower end of the pouch is open and the upper end isclosed. The flange member extends from one side of the belt to theother, as illustrated.

In the various embodiments of prophylactic devices of this invention,the sizes and thicknesses of the materials may vary. For example, thepouch member may have a length in the range of about 1 to 10 inches(preferably about 4 to 6 inches) and a diameter of about 1 to 4 inches.Although the pouch member may have a uniform diameter throughout itslength, the diameter could vary if desired.

The thickness of the wall material of the pouch member and the flangemember may also vary. For example, it may be as thin as 0.0005 inch oras thick as 0.1 inch. Preferably it is in the range of about 0.001 to0.005 inch. The pouch and the flange are preferably made of elastic,impermeable material such as natural rubber or synthetic rubber (e.g.,silicone rubber) Useful materials also include nonelastic materials suchas plastic (e.g., polyurethane, polyvinylchloride, etc.).

The flange member extends outwardly around the open end of the pouch atleast one inch, preferably three inches, and more preferably at leastfive inches. If desired, the flange member may be thicker than the wallportion of the pouch.

The closed end portion of the prophylactic devices intended for use byfemale persons may be resilient as described above, although this is notrequired in each embodiment. It has been found that the pouch is held inposition in the vagina by natural physiological force during and afterintercourse. The thickness of the closed end portion may vary.

FIG. 12 is a perspective view of a preferred type of mold 100 which isuseful in making devices of the invention which are in the form of abrief. The mold includes a general shape of a brief with an elongatedprotrusion 102 in the shape and size desired for the pouch member. Themold may be made of any suitable material such as ceramic, glass, hardplastic, etc. The mold is dipped into the material to be used in makingthe device (e.g., natural rubber latex) and then removed. After therubber cures or dries, the brief which is so formed can be removed fromthe mold. Leg openings are made in the sides of the brief.

FIGS. 13a and 13b illustrate a preferred and convenient manner fortelescoping and rolling the pouch member during manufacture andpackaging (i.e., prior to sale). As illustrated, the pouch member 112 ofthe device 110 is partially inverted as the device is being removed fromthe protrusion portion 102 of the mold. When the pouch is approximatelyone-half inverted, it has the appearance shown in FIG. 13a. Then thepouch member is rolled upon itself toward the flange member, asillustrated in FIG. 13B until it is completely removed from theprotrusion 102 of the mold. For example, brushes may be used to roll thepouch in this manner.

FIG. 13c illustrates the entire brief with the pouch member completelyrolled. The brief may be worn in this form until the time ofintercourse; then the pouch will easily unroll and extend into thevagina to the position illustrated by dotted line 112A.

Another embodiment of the present invention is illustrated in FIGS. 25through 27. They show an anatomically configured, hermaphroditicprophylactic device 120. The folded unit 120 includes a generallyrectangularly configured shield portion 122 having a narrow centralsegment 124 and a pair of end wing segments 126, 128. The wing segments126, 128 have a gradually tapering width which is bounded by a pair ofsegments 130, 132 of a continuously formed peripheral bead 134 whichconverge from a first end segment 133. A like pair of bead segments 136,138 formed on the sides of the wing portion 126 converge from a secondend segment 135 of the peripheral bead 134. Segments 136, 138 are joinedto central bead segments 140, 142 that are located in spacedparallelism. They are joined respectively to the inwardly convergentbead segments 130, 132.

The prophylactic device 120 further includes an integrally formed pouch144 that is centered in the center region 124 of the shield portion 122.The pouch 54 has an entrance opening 145. The pouch portion includes anend closure 146 that is joined to a rolled ring 148 that is formedduring a manufacturing process to be described The rolled ring 148 andthe end closure 146 are located on the inner surface 150 of theprophylactic device 120. More particularly, the inner surface 150 has alength from the extreme ends of the wing portions 126, 128 and a widthat the center region 124 to anatomically fit either a male or femaleuser to provide complete coverage of the perineum regions of a user toprevent bodily fluids from contacting such regions during use of theprophylactic device 120. As shown in FIG. 26, the rolled ring 148 has aprepackaged position 148a, a piloting position 148b and a fully extendedposition 148c (FIG. 15d).

More specifically, in the illustrated arrangement, the shield portion122 has a length L in the order of 22 cm. The maximum width WM of thewing portions 126, 128 is in the order of 12 cm and the center region124 has a width W of 9.5 cm and a height H of 6 cm. The wall thicknessesof the shield portion 122 and of the pouch 144 can be selected from theranges discussed with respect to the embodiment of FIGS. 1 and 2 and theother various embodiments.

The aforesaid dimensions are configured to anatomically relate to theperineum region of either a female user of the device or a male user ofthe device wherein the pouch 144 can be rolled from its stored positionin close spaced parallelism with the plane of the shield 122 to anextended position within a body cavity of a user.

One aspect of the present invention is that the rolled ring portion 148is configured so that the pouch 144 will unroll to form a single wallpiloting segment 152 shown in dotted line configuration in FIG. 26 uponfirst entry into the body cavity. The piloting segment 152 will becarried by further entry into a body cavity by unrolling the rolled ringsegment 148 from the shield portion 122 until the pouch 144 is fullydisposed as depicted at 155 within the body cavity (FIG. 15d).

One use representation of the prophylactic device 122 of the embodiments25 through 27 is somewhat diagrammatically illustrated in FIG. 14. Inthis representation, the prophylactic device 120 is secured to a strapsystem 154 that includes an elastic waist segment 154a that is insurrounding relationship to the waist of a male user. The strap system154 includes a pair of straps 156, 158. Each strap 156, 158 has fastenermeans 159 secured to corner segments 126a and 126b of the wing portion126. The strap system 154 further includes a pair of front located longstraps 160, 162 that are connected at one end to the waist segment 154aand at the opposite end thereof to corner segments 128a, 128b of thewing portion 128. The arrangement positions the shield portion 122 tocover the perineum region of a male user from the genital region 164thereof to a region above the anal canal 166 in the vicinity of thecoccyx region 168 of the male user.

Consequently, closure wall 146 of the pouch 144 is positioned inalignment with the anal passageway 166 while the bead portions 140, 142of the center region 144 are located in bridging engagement with theperineum 170 of the male user to shield such perineum regions frombodily fluids during use of the prophylactic device 120.

As shown in FIG. 15, the rolled ring 148 is located out of bodilycontact with the user so as to permit comfortable wear of theprophylactic device 120 prior to use. Upon use, the inside and outsideof the closure wall 146 can be suitably lubricated. Initial penetrationinto the body cavity represented by the anal passageway 166 causes thepiloting segment 152 to separate from the rolled ring 148 to form apiloted entrance and release of the pouch 144 into the anal canal 166.The pouch 144 is completely unrolled as shown in FIG. 15b upon furtherpenetration of the anal canal 166 so as to dispose the inner surface 150of the prophylactic device 120 in full shielding relationship with theperineum 170 during use. The full shielding relationship extends side toside of the perineum region 170 and from a region in the vicinity of thescrotum region 164 to the gluteal region.

In accordance with the present invention, the extent of the shielding bythe anatomically configured prophylactic device 120 is selected toprovide desired full coverage of a perineum region 170 of a male userwithout contacting extensive portions of the exterior body surface ofthe user in a manner which could cause discomfort. Nevertheless, theextent of the anatomic dimensions of the shield portion 122 are able tocover the aforedescribed perineum region 170 to prevent the exchange ofbodily fluids between the user of the prophylactic device and a personpenetrating and extending the pouch 144 of the device, thereby toprovide desired protection during use of the prophylactic device 120.

A further feature of the present invention is that the strap system 154is readily connected to and disconnected from a prophylactic device 120prior to and following use so as to enable the prophylactic device 120to be removed from the anal channel (or other body cavity) following usewithout an exchange of the bodily fluids to a person handling the pouch.More specifically, in order to assure such separation, the connectionsat each of the corner portions 122a, 122b, 128a, 128b is by use of asimple snap configuration including a male snap portion 172 that issecured to the end of the strap system 154 and a female snap portion 174on a split segment 176 of each of the straps as shown on the strap 160at the corner 128a in FIG. 14.

The arrangement enables the user to remove the strap system 154 andattached prophylactic device 120 from the user. The inside shieldedportion of the surface 150 can then be grasped at the split strapsegment 174 to unfasten the strap ends from the used prophylactic device120. The system enables the prophylactic device 120 to be removedfollowing use without unnecessary hand contact with bodily fluids on theouter surface 178 thereof.

Most bodily fluids shielded by the prophylactic device 120 areconcentrated within the interior cavity 180 of the extended pouch, whichis shown at 182 in FIG. 15b.

The anatomically configured, hermaphroditic condom 120 shown in FIGS. 25through 27 is equally suitable for use on a female person as shown inFIG. 16. In this embodiment, the prophylactic device 120 isrepresentatively shown as being connected to a bikini-like panty garmenthaving an elastic waist portion 184 with a buttocks engaging back panel186 and a shallow frontal segment 188. The back garment panel 186 isconnected to the corner regions 128a, 128b of the wing segment 128 bymale snap segments 190 on straps 192 to engage female snap components194 secured to the corner of the rear panel 186 of the bikini-likegarment. A like snap fastener assembly 196 connects the opposite cornerof the rear panel 186 to the corner region 128a of the wing portion 128.The front segment 184a of the elastic waist carries a plurality ofstraps 198a, b, c, and d each having a male snap formed thereon which,as shown in FIG. 16a includes a male fastener element 202 on the strap198a which is pressed through the corner segment or an edge of the wingsegment 126 to engage a female snap element 204 on the inner surface atthe lower edge of the shallow frontal segment 188.

The garment for carrying the prophylactic device 120 can also be in theform of a strap system as shown in FIG. 14 in which case the smallstraps 156, 158 will be located on the front of a female and the backlong straps 160, 162 will extend around the rear buttocks of a femaleuser of the prophylactic device 120. In either case, the prophylacticdevice 120 is located so that the end closure 146 is disposed incovering relationship to the vulva 204 at the entrance to a vaginalcanal 202 (FIG. 15d). The inner surface 150 of the shield portion 122 isthus disposed in protective overlying juxtaposed relationship with thevulva 204 and also covers the perineum regions 208 of the user extendingfrom the upper region of the pubic area to the perineum in the region ofthe anal orifice or canal of the female user. Thus, a substantialportion of the bodily surface of a female user is covered by theanatomically configured, hermaphroditic prophylactic device 120 withoutplacing a substantial portion of an elastic or plastic like syntheticmaterial against the outer surface of the user. Consequently, the devicecan be worn prior to use without discomfort.

The initial position of the prophylactic device 120 is shown in FIG. 15cat which point a portion of the exterior body surface of the female iscovered by the contraceptive device 120 to protect against bodily fluidexchange during normal use. The prophylactic device 120 can be carriedeither on a strap system of the type shown in FIG. 14 or on a bikinilike garment. Prior to extension of the rolled pouch 144 theprophylactic device 120 is disposed in overlying relationship but out ofengagement with the vulva 204 and other portions of the female personusing the prophylactic device. The end closure 146, however, ispositioned for ready disposition of the piloting segment 152 of thepouch 144 into the vaginal cavity 202 when a penis is insertedthereagainst to extend the pouch freely into the vaginal cavity 202. Thelength of the pouch 144 is greater than that of an erected penis andwill have a dimension which is great enough to extend the pouch to forma loose fitting cover of the walls of the vaginal cavity 202 as shown inFIG. 15C in diagrammatic form.

One feature of the present invention is that a forwardly located wallsegment 146a of the extended pouch is located in overlying relationshipto the clitoral region of a female user. Stroking movement of the peniswithin the vaginal canal will occur without undue contact between theglans region of the penis and the walls of the extended pouch 155. Thewall segment 146a is joined to the flat shield portion 122 at anexterior anchor point 122a thereof. The exterior anchor point 122a andthe wall segment 146a are operative during insertion and withdrawal of apenis from the interior of the extensible pouch to pleasurablystimulating the clitoral region during intercourse. Consequently, theprophylactic device 120 will not interfere with pleasurable use thereofduring coitus.

In accordance with other aspects of the present invention, theprophylactic device 120 of the present invention is formed by a processas set forth in FIGS. 18 through 20.

The process includes a mold 220 having a flat surface 222 thereon of aplanar extent corresponding to that of the planar extent of the shieldportion 122 bounded by the bead 134. The bead 134 is initially disposedat a bead support ridge 126 around the periphery of the flat surface122. The flat surface 222 has a protuberance 224 extending outwardly.The protuberance 224 has an outer surface 226 thereon dimensioned tocorrespond to that of the inside surface of the extended pouch 155.

In practicing the invention, the mold 220 is connected to suitablecarriage means for movement into an open ended container 228 that has abody of synthetic or latex material 230 therein of a composition asdiscussed in the earlier embodiments, which can be deposited on thesurfaces 222, 226 to form a resultant thin layer deposit thereon. Thedeposit can be formed by a single or double dip process which includesdirecting the mold 220 along a path 232 into the body of material 230 toform a layer of material on the surface 226. When the mold 220 islocated in the dotted line position shown in FIG. 18, it can be tiltedabout an arc 235 so as to deposit a thin layer of material across thesurface 222.

The resultant deposited material is shown in FIG. 19. The depositedmaterial is stripped from the mold 222 by relative movement between theformed shield portion 122 and the flat surface 222 of the mold 220whereby the shield portion 122 assumes the dotted line position shown byreference numeral 236 in FIG. 19. This causes the pouch portion of theprophylactic device to be telescoped upon itself to form a double walltelescoped segment 238. The double walled telescope segment 238 is thenengaged by suitable means such as rollers 240 to roll the telescopeddouble wall portion 238 upon itself from a return bend portion 242. Theresultant rolled ring 148 has an outer wall segment 148d which willunroll as the ring 148 assumes its piloting position 148b. It has aninner wall segment 148e which will unroll after the pilot portion 152 ispositioned. This rolled ring 148, as previously discussed, disposes theend closure 146 of the prophylactic device in close spaced parallelismwith the bead 134 which has latex formed therearound to form theperimeter of the prophylactic device 120.

The rolling of the ring 148 will remove the prophylactic device 120 fromthe form 220. The removed prophylactic device 120 can then be readilymanipulated for various forms of storage. For example, in FIGS. 22through 24, the prophylactic device 120 removed from the mold 220 can befolded end to end and then rolled from a joined end portion 240 to forma tubular configuration shown at 250 in FIG. 24. The tubularconfiguration is readily insertable into the interior of an elongatedcontainer 260 which is representatively shown as having a cap closure262. In this arrangement, each of the individual prophylactic devices120 are packaged separately from the garment or strap systems forconnecting the prophylactic device 120 for male or female use. Aspreviously discussed, the universal prophylactic device is anatomicallyconfigured to extend over the perineum regions of either a male or afemale user to shield such regions from bodily fluids during use.

The prophylactic device 120, as stripped from the mold 220, is alsoreadily foldable as shown in FIG. 25 to form a first joined end region256 which can be folded on itself to form a second folded end region 258that can be made even more compact by folding back upon itself to form athird fold region 260 thereby to define an eight layered compact condompackage 262 that is readily adapted for packaging in compact, flatcontainer configurations representatively shown at 264 in FIG. 22c.

In yet another embodiment of the invention, shown in FIG. 25 a plasticpouch 270 is formed from two thin film sheets 272, 274 of plastic thatare joined at their periphery 276. Suitable plastic film materialcontemplated by the invention includes polyvinylchloride, polyurethaneor polypropylene. The pouch 270 in this embodiment can be inelastic.However, it is dimensioned to provide freedom of movement of an erectedpenis with respect to a shielded vaginal canal and is also configured tobe rolled and unrolled with respect to a shield portion 278 of aconfiguration like shield portion 122. In this embodiment, the pouch 270has a flange 271 for attachment by suitable means around an entranceopening 280 in the shield portion.

Other variants are possible without departing from the scope of thepresent invention.

What is claimed is:
 1. A prophylactic device which is adapted to be wornby a person to prevent the transmission of disease and sperm duringsexual intercourse, said device comprising:(a) an elongated hollow pouchhaving first and second ends; said elongated hollow pouch having a leftthat covers substantially the full length of a vaginal tract; whereinsaid first end is closed and said second end includes an opening whereinsaid pouch includes a thin wall member which is flexible; (b) acontinuous flange member which is attached to said second end of saidpouch and which extends around the circumference of said opening; saidhollow pouch adapted to be inserted into the vagina of a female personand said pouch is elastic; and said first end of said pouch including aresilient portion comprising disc shaped retention member at said firstend of said pouch, wherein said disc shaped member is circumferentiallyenclosed thereby to apply radial pressure on said first end to engagethe wall of the vagina.
 2. A prophylactic device as claimed in claim 1wherein said disc shaped retention member is a resilient disc.
 3. Aprophylactic device as claimed in claim 2 wherein said resilient disc ismolded as an integral part of the pouch wall.
 4. A prophylactic deviceas claimed in claim 3 wherein said resilient disc is flexible.
 5. Aprophylactic device as claimed in claim 1 wherein said disc shapedretention member comprises a ring-shaped spring.
 6. A prophylacticdevice as claimed in claim 5 wherein said disc shaped member is formedas an integral part of the wall member of the pouch.
 7. A prophylacticdevice as claimed in claim 1 wherein said disc shaped member comprises aring shaped wire.
 8. A prophylactic device as claimed in claim 1 whereinsaid continuous flange member extends outwardly at least one inch aroundthe opening in the second end of the pouch.
 9. A prophylactic device asclaimed in claim 1 wherein said continuous flange member is elastic. 10.A prophylactic device as claimed in claim 1 wherein said continuousflange extends outwardly a distance of from 1 to 3 inches around theopening in the second end of the pouch.
 11. A prophylactic device asclaimed in claim 1 wherein a plurality of strap member are secured tosaid flange.
 12. A prophylactic device as claimed in claim 11 furtherincluding band adapted to be worn around the waist, and wherein the endsof said strap members opposite said flange are secured to said band. 13.A prophylactic device as claimed in claim 1 further including a rimmember surrounding said opening in the second end and detachably securedto said continuous flange member.
 14. A prophylactic device as claimedin claim 1 wherein said pouch is molded as an integral part of saidcontinuous flange member.
 15. A prophylactic device as claimed in claim14 wherein said continuous flange member is formed by a garment.
 16. Aprophylactic device as claimed in claim 1 wherein said continuous flangemember is formed separately from said pouch.
 17. A prophylactic deviceas claimed in claim 16 wherein said continuous flange member si formedby a garment detachably connected with the pouch.
 18. A femaleprophylactic device which is adapted to be worn by a female person,wherein said device includes an elongated hollow pouch having first andseconds ends; said elongated hollow pouch having a length that coverssubstantially the full length of a vaginal tract; wherein said first endis closed and is adapted to be inserted into the vagina of said femaleperson; wherein said second end includes an opening; wherein said pouchincludes a thin wall member which is flexible and elastic; said deviceincluding a continuous flange member attached to said second end of saidpouch; and said first end including a resilient portion comprising adisc shaped retention member at said first end of said pouch, whereinsaid disc shaped member is circumferentially enclosed thereby to applyradial pressure on said first end to engage the wall of the vagina. 19.A prophylactic device as claimed in claim 18 wherein said disc shapedretention member is a resilient disc.
 20. A prophylactic device asclaimed in claim 19 wherein said resilient disc is model as an integralpart of the pouch wall.
 21. A prophylactic device as claimed in claim 20wherein said resilient disc is flexible.
 22. A prophylactic device asclaimed in claim 18 wherein said disc shaped retention member comprisesa ring-shaped spring.
 23. A prophylactic device as claimed in claim 22wherein said disc shaped member is formed as an integral part of th wallmember of the pouch.
 24. A prophylactic device as claimed in claim 18wherein said disc shaped member comprises a ring shaped wire.
 25. Aprophylactic device as claimed in claim 18 wherein said continuousflange member extends outwardly at least one inch around the opening inth second end of the pouch.
 26. A prophylactic device as claimed inclaim 18 wherein said continuous flange remember is elastic.
 27. Aprophylactic device as claimed in claim 18 wherein said continuousflange member extends outwardly a distance of from 1 to 3 inches aroundthe opening in the second end of the pouch.
 28. A prophylactic device asclaimed in claim 18 wherein a plurality of strap members are secured tosaid continuous flange member.
 29. A prophylactic device as claimed inclaim 28 further including a band adapted to be worn around the waist,and wherein the ends of said strap members opposite said continuousflange member are secured to said band.
 30. A prophylactic device asclaimed in claim 18 further including a rim member surrounding saidopening in said second end and detachably secured to said continuousflange member.
 31. A prophylactic device as claimed in claim 18 whereinsaid pouch is molded as an integral part of said continuous flangemember.
 32. A prophylactic device as claimed in claim 31 wherein saidcontinuous flange member is formed by a garment.
 33. A prophylacticdevice as claimed in claim 18 wherein said continuous flange member isformed separately from said pouch.
 34. A prophylactic device as claimedin claim 33 wherein said continuous flange member is formed by a agarment detachably connected with the pouch.
 35. A female prophylacticdevice which is adapted to be worn by a female person, wherein saiddevice includes an elongated hollow pouch having first and second ends;said elongated hollow pouch having a length that covers substantiallythe full length of a vaginal tract; wherein said first end is closed andis adapted to be inserted into the vagina of said female person; whereinsaid second end includes an opening; wherein said pouch includes a thinwall member which is flexible and elastic; said device including acontinuous flange member attached to said second end of said pouch andpositionable exteriorly of the vaginal tract when said elongated hollowpouch is fully extended within the vaginal tract; said closed endincluding a resilient portion comprising a disc shaped retention memberat said closed end of said pouch, wherein said disc shaped member iscircumferentially enclosed thereby to apply radial pressure on saidfirst end to engage the wall of the vagina.
 36. A prophylactic device asclaimed in claim 35 wherein said disc shaped retention member is aresilient disc.
 37. A prophylactic device as claimed in claim 36 whereinsaid resilient disc is molded as an integral part of the pouch wall. 38.A prophylactic device s claimed in claim 37 wherein said resilient discis flexible.
 39. A prophylactic device as claimed in claim 35 whereinsaid disc shaped retention member comprises a ring-shaped spring.
 40. Aprophylactic device as claimed in claim 39 wherein said disc shapedmember is formed as an integral part of the wall member of the pouch.41. A prophylactic device as claimed in claim 35 wherein said discshaped member comprises a binge shaped wire.
 42. A prophylactic deviceas claimed in claim 35 wherein said continuous flange member extendsoutwardly at least one inch around the opening in said second end of thepouch.
 43. A prophylactic device as claimed in claim 35 wherein saidcontinuous flange member is elastic.
 44. A prophylactic device asclaimed in claim 35 wherein said continuous flange member extendsoutwardly a distance of from b 1 to 3 inches around the opening in saidsecond end of the pouch.
 45. A prophylactic device as claimed in claim35 wherein a plurality of strap member are secured to said continuousflange member.
 46. A prophylactic device as claimed in claim 45 furtherincluding a band adapted to be worn around the waist, stand wherein theends of said strap members opposite said flange are secured to saidband.
 47. A prophylactic device as claimed in claim 35 further includinga rim member surrounding said opening in said second end and detachablysecured to said continuous flange member.
 48. A prophylactic device asclaimed in claim 35 wherein said pouch is molded as an integral part ofsaid continuous flange member.
 49. A prophylactic device as claimed inclaim 48 wherein said continuous flange member is formed by a garment.50. A prophylactic device as claimed in claim 35 wherein said continuousflange member is formed separately from said pouch.
 51. A prophylacticdevice as claimed in claim 50 wherein said continuous flange member isformed by a garment detachably connected with the pouch.